The chronic migraine study is currently being carried out at nine clinics in Germany and Finland. The study has been delayed due to Covid-19, but is expected to initiate treatment of the last patients during the third quarter of 2021.
The results from an interim analysis of the first 53 patients were presented in May, 2019. The external data monitoring committee recommended that the study should continue according to plan, and that the number of patients participating in the study should remain unchanged. We interpret this as a strong indication that the study is likely to achieve the desired result. As the CE-mark already is in place based on the interim analysis data, the study is now moving forward towards completion to become a support in product launch and sales activities - and also constitute a foundation to understand our enterprize value.
Primary effect target: evaluate the effect of K.O.S. treatment through the decrease of the number of days/months with headaches with moderate to serious intensity.
Scope: <140 patients in nine clinics in Germany and Finland
Type: double-blind, randomized, placebo controlled
Inclusion: males/females in the 18-65 age bracket, migraine diagnosis <60 years of age, chronic migraine diagnosis< three months
Design: 50/50 randomized to active versus placebo treatment, 4 weeks screening, 6 weeks treatment, follow-up 4 weeks
A rhinitis study is currently being conducted in 13 clinics in six countries in the EU and the UK. An interim analysis that was performed during autumn 2020 showed that the statistical goals could not be achieved. Therefore patient recruitment was stopped. Follow-up of active patients will be conducted.
Primary effect target: evaluate the improvement effect of K.O.S. treatment on NAR (non-allergic rhinitis) with, among other things, Total Nasal Symptom Score (TNSS)
Scope: Around 300 patients in 13 clinics in six countries in the EU and the UK
Inclusion: males/females in the 18-65 age bracket, rhinitis diagnosis >12 weeks, nasal congestion estimated at >2 (on a scale of 0-3)
Design: 50/50 randomized to active vs placebo treatment, 10 days screening, two treatments at four-week intervals, follow-ups with 12 weeks intervals for 12 months
The effect of Chordate's treatment has been investigated in a number of studies over the years, where Chordate has often been the sponsor. These studies have been published in the articles below.
Ehnhage, A, Sahlstrand Johnsson P, et al Treatment of idiopathic rhinitis with kinetic oscillations – a multi- centre randomized controlled study. Acta Oto-laryngologica, 2016; 136(8):852-859
Juto JE, Axelsson M. Kinetic oscillation stimulation as treatment of non-allergic rhinitis: an RCT study. Acta Otolaryngol 2014; 134:506-12.
Fokkens et al. Rhinology Future Debates 2017 by EUFOREA: Novel treatments and surgical solutions in rhinology. Clinical Otolaryngology. 2018;1–10.
Fokkens et al. The Effect Of Kinetic Oscillation Stimulation On Symptoms Of Non-Allergic Rhinitis: A Per-Protocol Analysis Of A Randomized Controlled Trial. Journal of Otolaryngology Head & Neck Surgery, May 15, 2020 DOI:10.24966/OHNS-010X/100042
Nacie Bello Petersen and Knud Larsen. “Kinetic Oscillation Stimulation of Nasal Mucosa as Treatment for Non-allergic Rhinitis. A Pilot Study". Acta Scientific Otolaryngology 3.1 (2021): 39-42.
Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. Neurolmage: Clinical 2016; 451-459
Jan-Erik Juto, MSc, MD, PhD; Rolf G. Hallin, MD, PhD. Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study. Wiley Periodicals, Inc. 2014
Markus Jerling MD, Iwona Cygankiewicz, Nabil Al-Tawil, Borje Darpo, Anders Ljungström, Wojciech Zareba. Effects of intranasal kinetic oscillation stimulation on heart rate Variability. Ann Noninvasive Electrocardiol. 2017;e12474.
Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. NeuroImage: Clinical 12 (2016) 451–459
Sarin S. The role of the nervous system in rhinitis. J Allergy Clin Immunol 2006; 118:999-1016.
Safwan S. Jaradeh, MD; Timothy L. Smith, MD, MPH; Laura Torrico, MD; Thomas E. Prieto, PhD; Todd A. Loehrl, MD; Ronald J. Darling, MD; Robert J. Toohill, MD, FACS. Autonomic Nervous System Evaluation of Patients With Vasomotor Rhinitis. Laryngoscope 2000; 110:1828–1831
Hellings P.W., Klimek L., Cingi C., Agache I., Akdis C., Bachert C., Bousquet J., Demoly P., Gevaert P., Hox V., Hupin C., Kalogjera L., Manole F., Mösges R., Mullol J., Muluk N.B., Muraro A. , Papadopoulos N., Pawankar R. , Rondon C. , Rundenko M., Seys S.F., Toskala E., Van Gerven L., Zhang L., Zhang N., Fokkens W.J. Non-Allergic Rhinitis: Position paper of the European Academy of Allergology and Clinical Immunology. Allergy. 2017
K. Scadding, H. H. Kariyawasam, G. Scadding, R. Mirakian, R. J. Buckley, T. Dixon, S. R. Durham, S. Farooque, N. Jones, S. Leech, S. M. Nasser, R. Powell, G. Roberts, G. Rotiroti, A. Simpson, H. Smith, A. T. Clark, BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007), Clin Exp Allergy. 2017;47:856–889.
Pete Smith, David Price, Richard Harvey, Andrew Simon Carney, Vicky Kritikos, Sinthia Z Bosnic-Anticevich, Louise Christian, Derek Skinner, Victoria Carter, Alice Marie Sybille Durieux. Medication-related costs of rhinitis in Australia: a NostraData cross sectional study of pharmacy purchases. Journal of Asthma and Allergy. 2017:10 153–161
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